A study to learn how well Aflibercept injected into the eye works and how safe it is when given in customized treatment intervals in patients with an eye disease called neovascular age-related macular degeneration after start of treatment

Phase 1

• Conditions: eovascular (wet) age-related macular degeneration; MedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2022-000690-73-DE
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-15
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Written informed consent and able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member), understand, and willing to sign the ICF.
2. Men and women =50 years of age.
3. At treatment initiation, active macular neovascular lesions secondary to nAMD (Patients with polypoidal choroidal vasculopathy or retinal angiomatous proliferation are eligible to participate in the study, and their condition should be captured in the electronic case report form [eCRF]).
4. Treatment initiation with 3?×?monthly IVT aflibercept injections (Weeks?-16, -12, and -8 to planned study baseline visit) resulting in absence of any fluid at week?-8.
5. ETDRS BCVA of at least 25 letters (20/320 Snellen equivalent) in the study eye at screening visit.
6. Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
7. Able to use the provided monitoring device and willing to perform 5 × weekly self-assessments in the Investigator’s opinion.
8. Women and men of reproductive potential must agree to use adequate contraception when sexually active. This applies for the time period between signing of the ICF and 3 months after the last administration of study drug.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 103

Exclusion Criteria

1. Any contraindication to IVT anti-VEGF treatment or treatment with Eylea® as detailed in the Summary of Product Characteristics (SmPC).
2. Any prior ocular (in the study eye) or systemic treatment (including investigational agents) or surgery for nAMD, except the 3 × monthly IVT aflibercept injections required for treatment initiation and dietary supplements or vitamins.
3. Any presence of intraretinal and subretinal fluid.
4. Any ocular or systemic condition expected to interfere with study outcomes and procedures, including but not limited to:
• Scar, fibrosis or other lesions (e.g., retinal pigment epithelium [RPE] tears, macular hole stage 2 or above and others) involving the center of the macula in the study eye.
• Clinically relevant opacities or conditions involving the optic media including cataract, corneal dystrophies or s.p. corneal transplant in the study eye.
• Uncontrolled glaucoma (defined as IOP =25 mm Hg despite treatment with antiglaucoma medication) in the study eye or prior trabeculectomy or other filtration surgery in the study eye.
• Intraocular surgery, periocular surgery, or cataract surgery within 90 days before Day 1 in the study eye, except the IVT aflibercept injections required for treatment initiation and any history of vitrectomy, retinal radiation therapy, retinal detachment or treatment or surgery for retinal detachment in the study eye.
• Aphakia or pseudophakia with absence of posterior capsule (unless as a result of an yttrium aluminum garnet posterior capsulotomy) in the study eye.
5. Participation as a patient in any clinical study within 12 weeks before screening.
6. Close affiliation with the investigational site; e.g., a close relative of the Investigator, dependent person (e.g., employee or student of the investigational site).
7. Previously screen failed patients for this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified